Nucleus Rev 2021
Presentational Presentational

Percutaneous Transluminal Valvuloplasty (Canada)

NuCLEUS™ and NuCLEUS-X™

NuCLEUS™ and NuCLEUS-X™catheters feature an innovative balloon designed with a waist formed in the middle of the balloon to facilitate positive positioning while holding the balloon in the correct location prior to and during inflation. The NuCLEUS-X™ catheter features a braided inner tubing which provides high inner lumen strength for increased pushability. Upon reaching a specified pressure, the waist will expand between 90% to almost 100% of the rated balloon diameter. The NuCLEUS™ and NuCLEUS-X™ catheters are indicated for PTV of the mitral and aortic valves. The NuCLEUS™ is available in diameters ranging from 10.0-30.0mm and lengths of 3.0-6.0cm, and the NuCLEUS-X™ is available in diameters ranging from 18.0-30.0mm and lengths of 4.0-6.0cm.

Unique Benefits

NuCLEUS™ and NuCLEUS-X™ PTV catheters are coaxially constructed with a non-compliant high pressure balloon suitable for resistant stenosis. The balloon design facilitates precise positioning and helps to maintain the correct balloon location throughout the procedure. The NuCLEUS-X™ has an extra high inner lumen strength due to the braided inner tubing. The increased pushability of the coaxial shaft provides outstanding tracking performance.  They have extremely fast inflation and deflation times for a quick procedure.  

The catheter body is Polymeric, DEHP-free, and not made with natural rubber latex. The balloon is a thermoplastic elastomer; non-compliant - which will not exceed +/- 10% of the labeled balloon size at RBP, is DEHP-free, and not made with natural rubber latex.

  • Balloon Diameters (mm): 10.0-30.0
    Balloon Lengths (cm): 3.0-6.0
    Rated Burst Pressure (ATM): 2-9
    Introducer Size (FR): 7-14
    Indication: PTV of the Mitral & Aortic Valve

    NuCLEUS™ IFUs:

    INTERNATIONAL: RM0425-20 
    CANADA: RM0425-20

    Post Market Surveillance Form NCI

  • Balloon Diameters (mm):  18.0-30.0
    Balloon Lengths (cm):  4.0-6.0
    Rated Burst Pressure (ATM): 2-4
    Introducer Size (FR):  10-14
    Indication:  PTV of the Mitral & Aortic Valve
     

    NuCLEUS-X™

    CANADA: RM0425-25
    INTERNATIONAL: RM0344-30, RM0425-25

    Post Market Surveillance Form NCI

Balloon Diameter (mm) Balloon Length (cm) Introducer (FR) Shaft Size (FR) Usable Length (cm) Guide Wire (inches) Rated Burst Pressure (ATM) Catalog Number Product
10.0 3.00 7 6.0 110 0.035 9.0 PVN218 NUCLEUS
10.0 4.00 7 6.0 110 0.035 9.0 PVN219 NUCLEUS
10.0 5.00 7 6.0 110 0.035 9.0 PVN236 NUCLEUS
10.0 6.00 7 6.0 110 0.035 9.0 PVN237 NUCLEUS
12.0 3.00 7 6.0 110 0.035 7.0 PVN220 NUCLEUS
12.0 3.00 8 6.0 110 0.035 7.0 PVN221 NUCLEUS
12.0 4.00 7 6.0 110 0.035 7.0 PVN222 NUCLEUS
12.0 4.00 8 6.0 110 0.035 7.0 PVN223 NUCLEUS
12.0 5.00 8 6.0 110 0.035 7.0 PVN238 NUCLEUS
12.0 6.00 8 6.0 110 0.035 7.0 PVN239 NUCLEUS
14.0 3.00 9 7.0 110 0.035 6.0 PVN224 NUCLEUS
14.0 4.00 9 7.0 110 0.035 6.0 PVN225 NUCLEUS
14.0 5.00 9 7.0 110 0.035 6.0 PVN240 NUCLEUS
14.0 6.00 9 7.0 110 0.035 6.0 PVN241 NUCLEUS
16.0 3.00 9 7.0 110 0.035 5.0 PVN226 NUCLEUS
16.0 4.00 9 7.0 110 0.035 5.0 PVN227 NUCLEUS
16.0 5.00 9 7.0 110 0.035 5.0 PVN242 NUCLEUS
16.0 6.00 9 7.0 110 0.035 5.0 PVN243 NUCLEUS
18.0 3.00 10 8.0 110 0.035 4.0 PVN228 NUCLEUS
18.0 4.00 10 8.0 110 0.035 4.0 PVN229 NUCLEUS
18.0 4.00 10 9.0 110 0.035 4.0 PVN400 NUCLEUS-X
18.0 5.00 10 8.0 110 0.035 4.0 PVN244 NUCLEUS
18.0 5.00 10 9.0 110 0.035 4.0 PVN401 NUCLEUS-X
18.0 6.00 10 8.0 110 0.035 4.0 PVN245 NUCLEUS
18.0 6.00 10 9.0 110 0.035 4.0 PVN402 NUCLEUS-X
20.0 4.00 12 8.0 110 0.035 4.0 PVN230 NUCLEUS
20.0 4.00 12 9.0 110 0.035 4.0 PVN403 NUCLEUS-X
20.0 5.00 12 8.0 110 0.035 4.0 PVN246 NUCLEUS
20.0 5.00 12 9.0 110 0.035 4.0 PVN404 NUCLEUS-X
20.0 6.00 12 8.0 110 0.035 4.0 PVN247 NUCLEUS
20.0 6.00 12 9.0 110 0.035 4.0 PVN405 NUCLEUS-X
22.0 4.00 12 9.0 110 0.035 3.0 PVN406 NUCLEUS-X
22.0 4.00 12 9.0 110 0.035 4.0 PVN231 NUCLEUS
22.0 5.00 12 9.0 110 0.035 3.0 PVN407 NUCLEUS-X
22.0 5.00 12 9.0 110 0.035 4.0 PVN248 NUCLEUS
22.0 6.00 12 9.0 110 0.035 3.0 PVN408 NUCLEUS-X
22.0 6.00 12 9.0 110 0.035 4.0 PVN249 NUCLEUS
25.0 4.00 12 9.0 110 0.035 3.0 PVN409 NUCLEUS-X
25.0 4.00 12 9.0 110 0.035 4.0 PVN232 NUCLEUS
25.0 5.00 12 9.0 110 0.035 3.0 PVN410 NUCLEUS-X
25.0 5.00 12 9.0 110 0.035 4.0 PVN250 NUCLEUS
25.0 6.00 12 9.0 110 0.035 3.0 PVN411 NUCLEUS-X
25.0 6.00 12 9.0 110 0.035 4.0 PVN251 NUCLEUS
28.0 4.00 12 9.0 110 0.035 2.0 PVN233 NUCLEUS
28.0 4.00 12 9.0 110 0.035 2.0 PVN412 NUCLEUS-X
28.0 4.00 14 9.0 110 0.035 2.0 PVN234 NUCLEUS
28.0 5.00 12 9.0 110 0.035 2.0 PVN413 NUCLEUS-X
28.0 5.00 14 9.0 110 0.035 2.0 PVN252 NUCLEUS
28.0 6.00 12 9.0 110 0.035 2.0 PVN414 NUCLEUS-X
28.0 6.00 14 9.0 110 0.035 2.0 PVN253 NUCLEUS

Disclaimer

All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.